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Gastric CancerNCT07755917

Preoperative Home-based Multimodal Prehabilitation Based on 5G + Artificial Intelligence Mobile Health

A study testing mHealth prehabilitation group and ERAS group in people with Gastric Cancer and Prehabilitation, run by The Affiliated Hospital of Qingdao University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

The goal of this prospective, multicenter, open-label randomized controlled clinical trial is to evaluate whether a home-based, digitally supervised multi-modal prehabilitation intervention can improve functional capacity, treatment tolerance, and short- and long-term clinical outcomes in gastric cancer patients who… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Gastric Cancer, Prehabilitation
What is being tested?
mHealth prehabilitation group and ERAS group
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
490 participants
Where
No sites listed yet
Study dates
31 Aug 2026to 1 Sep 2030
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Aged 18 years or older
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
  • Histologically confirmation of gastric or gastroesophageal junction (GEJ) adenocarcinoma. For GEJ carcinomas, eligibility is strictly confined to those presenting with Siewert type III tumors or Siewert type II tumors that do not mandate a concurrent thoracotomy
  • Surgery is planned after neoadjuvant therapy
  • Capacity to comprehend and voluntarily sign a written informed consent form
  • Ability to use digital technology (e.g., smart phones, wearable devices) independently or with the assistance of family members

Who cannot join

  • Distant metastasis
  • Severe cardiac dysfunction (preoperative LVEF < 30% or NYHA classification IV), severe liver dysfunction (Child-Pugh C grade), severe kidney dysfunction (preoperative CRRT was received), ASA grade IV or above; 6MWD ≤ 250 meters
  • Within 6 months before enrollment, the patient had experienced cerebral hemorrhage, cerebral infarction, TIA, or suffered from central nervous system diseases or mental disorders, and was unable to cooperate in completing neoadjuvant therapy and prehabilitation
  • Presence of severe systemic infections (e.g., multiple organ dysfunction syndrome [MODS]) or active infectious diseases (e.g., tuberculosis)
  • Emergency surgery is required due to complications of the tumor (e.g. bleeding, perforation, obstruction)
  • Simultaneous tumors or other diseases requiring simultaneous surgery (excluding laparoscopic cholecystectomy)
  • Patients who are participating in any other clinical trials (except observational, non-interventional clinical study)

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Yulong Tian contact

86532-82911324

zhouyanbing@qduhospital.cn

Yanbing Zhou contact

86532-82911324

zhouyanbing@qduhospital.cn

About this study

Official title: Preoperative Multi-mode Prehabilitation Management for Neoadjuvant Chemotherapy Gastric Cancer Patients Supervised at Home Based on 5G + AI Mobile Health (mHealth): A Multicenter RCT

The goal of this prospective, multicenter, open-label randomized controlled clinical trial is to evaluate whether a home-based, digitally supervised multi-modal prehabilitation intervention can improve functional capacity, treatment tolerance, and short- and long-term clinical outcomes in gastric cancer patients who have completed 2-4 cycles of neoadjuvant chemotherapy and are scheduled for radical gastrectomy.

Read the detailed description

The main questions it aims to answer are: Does digital multi-modal prehabilitation reduce the postoperative comprehensive complication index (CCI) compared to conventional care? Does the intervention improve perioperative functional capacity (e.g., 6-minute walk distance, cardiopulmonary function), nutritional status, psychological well-being, chemotherapy adherence, and long-term survival outcomes (3-year overall and disease-free survival)? Researchers will compare the experimental group (receiving at least 2 weeks of 5G+AI digitally supervised home-based multi-modal prehabilitation plus standard ERAS perioperative management) to the control group (receiving conventional management plus standard ERAS perioperative management) in a 1:1 randomization to see if the digital prehabilitation approach significantly lowers postoperative complications, enhances functional reserve, improves nutritional and psychological status, and optimizes recovery and survival.

Being tested
mHealth prehabilitation group, ERAS group
Keywords
gastric cancer, prehabilitation
Medical subject headings
Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • mHealth prehabilitation groupBehavioural

    receiving at least 4 weeks of 5G+AI digitally supervised home-based multi-modal prehabilitation plus standard ERAS perioperative management

  • ERAS groupOther

    The management of ERAS group was carried out in accordance with the standard ERAS protocol from admission until 30 days postdischarge. The ERAS program mainly included malnutrition screening, health education, surgical risk assessment, and smoking and drinking cessation.

Study groups in NCT07755917
Study groupRoleWhat they receive
prehabilitation groupExperimentalThe prehabilitation group will receive preoperative multimodal prehabilitation combined with ERAS before gastrectomy.
Receives: Behavioral: mHealth prehabilitation group
ERAS groupPlacebo comparatorThe ERAS group patients will be managed according to the ERAS pathway.
Receives: Other: ERAS group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. postoperative complications

    comprehensive complication index (CCI)

    Measured: postoperative 30 days

Secondary outcomes (7)

  1. six minute walk test (6MWT)

    The 6MWT evaluates the ability of an individual to maintain a moderate level of physical activity over a time period reflective of the activities of daily living. Subjects are instructed to walk back and forth, in a 20 m stretch of hallway, for six minutes, at a pace that would make them tired by the end of the walk; encouragement and feedback are given according to published guidelines.

    Measured: Baseline, before surgery

  2. Oncological outcomes

    3-year recurrence-free survival and 3-year overall survival

    Measured: 3 years after surgery

  3. psychological states

    Psychological states was measured by Hospital Anxiety and Depression Scale (HADS). Higher scores indicate more severe anxiety or depression symptoms.

    Measured: Baseline, Before surgery

  4. Quality of life - EORTC QLQ-C30

    For the functional scale and the overall quality of life scale, the higher the score, the better the function or quality of life; for the symptom scale/items, the higher the score, the more severe the symptoms or problems. The comprehensive score of QLQ-C30 is calculated based on the average of the scores of the 13 domains of the QLQ-C30 scale (excluding overall life quality and economic impact). The higher the score, the better the health-related quality of life.

    Measured: Baseline, Before surgery

  5. Quality of life-EORTC QLQ-STO22

    Gastric cancer-specific quality of life assessed using the EORTC Quality of Life Questionnaire - Stomach Cancer Module (EORTC QLQ-STO22). The questionnaire includes five multi-item scales (dysphagia, pain, reflux, eating restrictions, anxiety) and four single items (dry mouth, body image, taste problems, hair loss). Higher scores indicate more severe symptoms.

    Measured: Baseline, Before surgery

  6. Prognostic Nutritional Index (PNI)

    The Prognostic Nutritional Index (PNI) is calculated based on serum albumin and lymphocyte count. The formula is: PNI = Serum albumin (g/dL) × 10 + Lymphocyte count (×10⁹/L) × 0.005. ≥45: Low risk, with good nutritional and immune status; 35-44: Medium risk, there may be mild malnutrition or immunosuppression; <35: High risk, indicating severe malnutrition or impaired immune function.

    Measured: baseline, piror to surgery

  7. postoperative hospital stay

    Measured: Postoperative 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Aug 2026
  2. Study start31 Aug 2026 (estimated)
  3. Primary completion1 Sep 2028 (estimated)
  4. Study completion1 Sep 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
490 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07755917
Sponsor's protocol ID
GISSG-PREHAB2603
Status last verified
Aug 2026
First submitted
2 Aug 2026
Last updated
10 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing mHealth prehabilitation group and ERAS group in people with Gastric Cancer and Prehabilitation, run by The Affiliated Hospital of Qingdao University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Yulong Tian (86532-82911324, zhouyanbing@qduhospital.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

postoperative complications (time frame: postoperative 30 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07755917.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.

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